JP2010533044A - Drug takeout container and method - Google Patents

Abstract

An apparatus for containing and removing a medicament for a patient diagnosed with a type of macular degeneration, preferably at least one panel, for preventing macular degeneration and for the progression of macular degeneration. A container having an interior configured to contain multiple doses of medication to be administered to the patient for delay, and a diagnostic chart on the panel that allows the patient to perform an eye self-test. A device in which the eye self-test is involved in the diagnosis of macular degeneration and / or progression of macular degeneration.
[Selection] Figure 1

Description

Inventor:
Steve H., an American citizen of Michigan and Ann Arbor Kanzer

Assignee:
United States 48108 Michigan, Ann Arbor, Varsity Drive 3930 Pipex Pharmaceuticals, Inc. (United States, Delaware Corporation)

Related Application Indications The priority of US Provisional Patent Application No. 60 / 948,827 filed July 1, 2007, which is incorporated herein by reference, is claimed.
Priority is claimed to US Provisional Patent Application No. 60 / 987,024, filed Nov. 9, 2007, which is incorporated herein by reference.

No mention of federally funded research and development.

See “Microfish appendix” None.

1. FIELD OF THE INVENTION The present invention relates to a drug retrieval container that contains drugs such as pills and tablets, which are taken out by patients diagnosed with age-related macular degeneration (AMD). The container allows the patient to repeat self-tests by placing a self-test chart or grid on the surface of the container as part of a specially configured pill removal device.

2. General Background of the Invention Age-related macular degeneration is a leading cause of blindness in people over 50 years and accounts for approximately 30% of people over 75 years of age. Ninety percent of patients with AMD are in an early form known as dry AMD and the remaining 10% are already converted to a very devastating late form known as wet or wet AMD is doing. David A. Since 1988 when Newsam first demonstrated the effectiveness of daily oral zinc therapy for dry AMD, dry AMD treatment seeks to achieve two distinct goals: (1) prevention of disease progression with daily treatment with ocular vitamins and (2) early detection of retinal events indicating the possibility of conversion from dry to wet is there. New ambitious therapies such as anti-VEGF inhibitors (anti-vascular endothelial growth factor inhibitors) injected intraocularly are useful to stop the progression of wet AMD, but patient outcomes are How early AMD is detected and treated depends very much on the importance of early detection.

  The following prior art that may be relevant is cited by the inventors to further demonstrate the novelty and utility of the present invention over the prior art.

  US Pat. No. 6,874,652 describes a tablet dispenser contained in a blister pack, but does not describe an eye self-test or mounting position.

  International Publication No. WO 2004/000703 A1 describes a dispenser that removes solids, but does not describe an eye self-test or mounting position.

  US Pat. No. 5,133,478 describes a removable pill dispenser that organizes a patient's calendar for different medications that are particularly useful as an aid in reducing vision, but does not describe eye self-tests However, it does not specifically explain the extraction of drugs useful for AMD.

  U.S. Pat. No. 6,494,579 describes a removable eye self-test device that informs the user at specific intervals that it is time to perform an eye self-test. . However, this patent does not describe, incorporate, or assist in the compliance or retrieval of medication. On the contrary, this device relies on visual or audio means to remind the patient to do an eye self-test and, like all other prior art, the daily medication administration and the practice of medication compliance. Rely solely on compliance with self-test of the patient's eyes, who are far away.

  US Patent Publication No. 2004/0091454 requires a right to a method of treating AMD with administration of a “selective cytokine inhibitor”. This patent application is also referred to in paragraph [0028] as a “selective cytokine inhibitor, or a pharmaceutical comprising a pharmaceutically acceptable salt, solvate, hydrate, stereoisomer, clathrate or prodrug thereof. A kit comprising the composition, the invention further comprising a kit comprising a plurality of single unit dosage forms, and the kit included in the invention may further comprise an active agent. Includes an Amsler grid useful for detecting or diagnosing MD ". This application, in paragraph [0283], “The kit of the present invention may further comprise a device used to administer the active agent. Examples of such devices include syringes, drip bags, patches. And, but not limited to, inhalers. The kit of the present invention may further comprise an Amsler grid useful for detecting or diagnosing MD. " This kit is distinct from the present invention. Because it is not expected to improve compliance by combining the pill dispenser and eye self-test and combining the two functions. This kit merely illustrates the inclusion of an Amsler grid in the kit and does not provide removal or attachment means. This kit is similar to including an Amsler grid in or with a package insert in a carton containing a typical bottle of Bauschloom Preser Vision, Ocubite, or Alcon Eye Caps. Once the Amsler grid is separated from the medication bottle, the daily behavior of pill administration is completely from the daily routine of the eye self-test, as most Amsler grids are currently given to patients by ophthalmologists. Will be separated.

  Personal digital assistants ("PDAs") are handheld computers, but have become increasingly multifunctional over the years. PDAs are also known as pocket computers and palmtop computers. PDAs have many uses: calculation, use as a clock or calendar, access to the Internet, sending and receiving e-mail, video recording, typewriting and word processing, use as an address book, spreadsheet creation and writing, Scanning barcodes, using as radio or stereo, playing computer games, recording survey responses, global positioning system (GPS). A modern PDA also has both a color screen and an audio function, allowing it to be used as a mobile phone (smartphone), web browser, or portable media player. Many PDAs can access the Internet, intranets or extranets via Wi-Fi or wireless wide area networks (WWANs). Many PDAs use touch screen technology.

  Currently, a typical personal digital assistant, or “PDA”, has a touch screen for entering data, a memory card slot for recording data, and at least one connectivity of IrDA, Bluetooth and / or WiFi. ing. However, many PDAs (typically those used primarily as phones) do not have a touch screen and use soft keys, directional pads, numeric keys, or thumb keyboards for input.

  The device of the present invention is a device that contains a medicine (eg, pill, tablet, powder) and is taken out by a patient diagnosed with a type of macular degeneration. The device includes a specially configured container for containing the medication to be removed and a diagnostic chart on the container, the diagnostic chart being used by the patient to self-test the eye each time the patient removes the medication from the container. Makes it possible to do.

  The present invention provides great convenience to patients with dry AMD by co-reinforcing the daily routine of self-tests that detect retinal events early and the daily routine of pill administration. And improve patient compliance. The present invention accomplishes this by incorporating both routines into a single device, allowing both tasks to be performed by the patient relatively simultaneously. In this way, the routine of the eye self test enhances compliance with the daily pill dosing regimen, and the daily routine of pill administration enhances the self test of the eye. The present invention gives the prescribing physician great confidence that the patient will follow the routine eye self-test instructions from the prescribing physician during the routine checkup.

  Examples of the present invention are pill (or other oral drug delivery techniques or means such as chewable or effervescent tablets, capsules, tablets or powders) dispensers or containers, such as an Amsler grid, a “blind spot” Amsler grid, or Eye self-tests for early detection of retinal events, such as peripheral hyperacuity self-test, with or including a plane with sufficient area to display in printed and / or electronic form, for example It is out. In a preferred embodiment, the present invention can include a written or electronic recording means such as a touch screen, which records the results of the patient's self test on one or more Amsler grids using a pen or the like. In such a case, the present invention optionally and preferably includes a test of the patient's eyesight, in which the patient touches the touch screen with a finger or device and the result of the test Are preferably recorded for consideration by the patient or their physician.

  In preferred embodiments, the present invention is optionally mounted on a refrigerator, wall, or stand to further aid compliance.

  In one embodiment, the present invention can include a touch screen device that allows a patient to touch and test their vision.

  In one embodiment, the present invention selectively involves voice drive / recognition (e.g., a wireless microphone, Bluetooth capable and including voice recognition technology) instead of a touch screen, Includes a computer monitor or computer screen. Such voice driving / recognition can identify user response to letters and / or symbols shown on the screen to measure and / or monitor patient vision in various lighting and visual conditions Would be.

  In a further preferred embodiment, the present invention may include or comprise a pill supply by a blister card so that the eye self-test can be applied to a fragile surface applied to the blister card or to a container surrounding the blister card. Imprinted on. (See, for example, FIGS. 1, 2 and 3.)

  In a further preferred embodiment, the present invention comprises a mass magazine of pills, a bulk pill, or a blister card of pills (tablets or powders), mechanically and / or electrically activated, Equipped with a pill dispenser that allows the patient to remove a pill or daily pill, so that the eye self-test is imprinted and integrated on a flat surface.

  In a further embodiment, the dispenser incorporates emergency contact information, allowing the patient to contact if the patient suspects that a retinal event may have occurred.

  In further embodiments, the written or electronic recording means can be stored and used by the patient and / or doctor to monitor the progression of the patient's illness.

  In a preferred embodiment, the present invention includes two different eye self-tests, one for the left eye and the other for the right eye. The eye self-test includes an Amsler grid, which appears light against a dark background and dark against a light background.

  The present invention may include a writing instrument or a touch screen stick as the recording means.

  The present invention may incorporate magnetic or adhesive strip or hanger means for attachment to a door or wall.

The present invention is disposable or includes disposable components, such as a pill magazine or blister card that is integrated with an eye self-test device.

  In a preferred embodiment of the invention, the flat surface includes one or more Amsler grids and includes a housing containing one or more blister cards containing pills. The patient pulls out the blister card (see Figures 1 and 2) or drives the hinge to expose the blister card, approach the pill, push the Amsler grid, or push the PVC layer on top of the blister card Then, the lower foil layer is crushed, and the pill is pushed through a stiff grid to release the pill from the empty free space and free fall by gravity onto the collection tray at the bottom of the dispenser (FIGS. 3-5). See).

  In a preferred embodiment, the blister card may remain exposed under the printing calendar in proximity to the eye self test.

  In a preferred embodiment, a blister card containing pills may be configured, for example, so that seven columns correspond to days of the week and rows correspond to week of the month and / or times per day.

  Alternatively, the blister card may place the pills in a circular blister wheel layout, with the mechanism within or behind the eye self-test pushing out the pills while pushing out the rotating blister wheel. It may be possible to proceed to the next pill to be done. This is described in detail in US Pat. No. 6,874,652 (see FIG. 6).

  In a preferred embodiment, the present invention includes a removable pill dispenser, the pill dispenser comprising zinc monocysteine, zinc, lutein, vitamin A, vitamin C, vitamin E, and related eyes. A pill containing one or more optional elements selected from the group consisting of prescriptions for Age-Related Eye Disease Study 1 (AREDS 1) is taken out.

  In a preferred embodiment, the present invention comprises a blister card type pill dispenser that is attached to a refrigerator or wall by magnetic, adhesive, claw, screw or hook. Thus, when pushed, the building is pushed out of the free space behind the grid through the grid and falls into the collection tray.

  In a preferred embodiment, the present invention comprises a bulk fill or cartridge type pill dispenser, and is a desiccant and / or product stability (as described in WO 2004/000703 A1). Moisture barrier means may be provided to maintain the characteristics of Also, the pill dispenser is attached to the refrigerator or wall by magnetism, adhesives, nails, screws, or hooks, so that when pushed, the bill or pills fall to the collection tray by gravity.

  In a preferred embodiment, the bulk fill pill container or pill cartridge may be filled and prepared by a pharmacist, placed or mounted in the device, by an actuator driven by a patient, or electrically programmable means. Are automatically released individually by automatic operation using or using electronic visual means such as LED indicators that are visible to the patient. The device may be tailored to the general mouth and thread size of a plastic medical bottle. Preferably, the medicinal bottle is inverted with respect to the removal or special disposable cartridge provided to the filling pharmacist.

  The eye self-test may be in the form of a torn or rolled sheet, and the results of the test may be recorded and stored on the sheet separately from or within the apparatus.

  The pill dispenser may incorporate other activation mechanisms such as an optional lock that the child cannot control or a simultaneous dual activation mechanism.

  The present invention may include a collection tray at the bottom to collect pills removed from the vertical mounting position. In a preferred embodiment, the present invention may retrieve two or more pills corresponding to the recommended number of daily capacities. Therefore, after performing a single eye test in the morning, the patient drives the device to release multiple pills, and the patient takes one pill immediately and the remaining pills removed You can save them as reminders and take them later.

  In a preferred embodiment, the patient pushes a push button that is spring-biased, such as placed or having an Amsler grid, in the middle, middle, bottom, top or back of the Amsler grid. However, one or more pills may be mechanically or electrically removed (see FIG. 3).

  The present invention also preferably includes a removable calendar combined with one or more eye self tests. In a preferred embodiment, the present invention may provide a means to remind the patient of the next scheduled patient appointment for the treating physician. The present invention may also be printed or affixed with communications and other information relating to the treating physician.

  In a preferred embodiment, the present invention may also comprise a calendar style pill dispenser incorporating an eye self test, the pill dispenser comprising a plurality of containers arranged in a matrix, for use in AMD medicine. In addition, it may correspond to the day and / or time of the week and may be filled with other medications for the patient that help reduce the patient's vision. This helps AMD patients to be properly administered other daily medications.

  In a preferred embodiment, the present invention may comprise one or more active ingredients selected from the group consisting of zinc monocysteine, zinc, lutein, vitamin A, vitamin C, vitamin E, and AREDS1.

  Preferably, the active ingredient slows, stops or more preferably reverses the progression of the disease.

  All materials used or intended to be used by humans are biocompatible unless otherwise noted.

For a further understanding of the nature, objects and advantages of the present invention, the following detailed description should be read in conjunction with the accompanying drawings. In the drawings, like reference numerals indicate like elements.
FIG. 1 is a front view of a preferred embodiment of the apparatus of the present invention. FIG. 2 is a side view of a preferred embodiment of the apparatus of the present invention, showing the blister card sliding out of the container. FIG. 3 is a perspective view of a preferred embodiment of the apparatus of the present invention. 4 is a cross-sectional view taken along line 4-4 of FIG. FIG. 5 is a cross-sectional view taken along line 5-5 of FIG. FIG. 6 is a perspective view of another embodiment of the apparatus of the present invention. FIG. 7 is a perspective view of a preferred embodiment of the apparatus of the present invention, mounted on a vertical surface of an appliance cabinet. FIG. 8 is a partial view of a preferred embodiment of the apparatus of the present invention. FIG. 9 is a rear perspective view of a preferred embodiment of the apparatus of the present invention. FIG. 10 is a rear perspective view of a preferred embodiment of the apparatus of the present invention. FIG. 11 shows another embodiment of the present invention. FIG. 12 shows another embodiment of the present invention. FIG. 13 shows another embodiment of the present invention. FIG. 14 shows another embodiment of the present invention. FIG. 15 shows another embodiment of the present invention. FIG. 16 shows another embodiment of the present invention. FIG. 17 shows another embodiment of the present invention. FIG. 18 shows another embodiment of the present invention. FIG. 9 shows another embodiment of the present invention. FIG. 20 shows another embodiment of the present invention. FIG. 21 shows another embodiment of the present invention. FIG. 22 shows another embodiment of the present invention. FIG. 23 shows another embodiment of the present invention. FIG. 24 shows another embodiment of the present invention. FIG. 25 shows another embodiment of the present invention. FIG. 26 shows another embodiment of the present invention. FIG. 27 shows another embodiment of the present invention. FIG. 28 shows another embodiment of the present invention. FIG. 29 shows another embodiment of the present invention. FIG. 30 shows another embodiment of the present invention.

  Figures 1-2 and 4 show a preferred embodiment of the device of the present invention, which device is generally indicated by reference numeral (10). The drug removal device (10) comprises a container or container (11) that can be composed of a plurality of panels, which are internal or hollow holding a pill receiving insert (e.g. a blister card) (20). Enclose space.

  Thus, the container / container (11) includes a pair of side panels (12), (13), a pair of rear panels (14), (15), a bottom panel (16), and a top panel (17). It's okay. The container or container (11) may include one or more closure flaps (18) that are opened to expose and remove the pill receiving insert (20). The closure flap (18) may be placed on the panel (14) or (15) and attached to the insert (20) (see FIGS. 2 and 4).

  The tab (29) of the flap (18) can be used to remove the insert (20) from the interior of the container or container (11). The upper panel (17) has a self-test chart (19) of the eye like a grid, allowing the patient to perform an eye self-test. At the same time that the patient performs an eye test, the patient removes the medication. The medicament may be in the form of a pill (24).

  The pill containment insert (20) thus contains a plurality of pills / medicines (24) to be removed. As shown in FIGS. 2, 4 and 8, the insert (20) includes a plurality of pill-receiving hollow spaces (25), each of which is a pill (24) or other known form of others. Have a medication or prescription drug, for example one or more doses of medication prescribed to the patient's doctor.

  The pill receiving insert (20) may include a laminated layer (22) (eg, PVC or other plastic) laminated to the foil layer (21) (see, eg, FIG. 8). The window or opening (23) of the layer (22) is covered with a foil layer (21). Furthermore, each pill (24) is covered by a transparent layer (26), such as a transparent plastic layer, allowing the patient to see the pill (24) being removed. The pill (24) to be taken out is usually arranged in the hollow space (25) between the foil layer (21) and the transparent layer (26) in this way.

  The bottom panel (16) of the container / container (11) may be attached to a hanger, the hanger being a selected panel or surface (57), such as a wall or electrical equipment (55) (e.g. a refrigerator), Alternatively, the container / container (11) is mounted on any other generally inclined or vertical surface. Such a hanger may be, for example, in the form of a magnetic strip (27) (FIG. 9) or an adhesive strip (28) (FIG. 10), the adhesive strip (28) covered with a removal liner that is discarded. It may be a release adhesive tape such as a foamable adhesive layer. The hanger (27) or (28) may be used in either the embodiment of FIGS. 1 to 5 or the embodiment of FIG.

  FIGS. 3 and 5 show another preferred embodiment of the device, identified by reference numeral (30). 3 and 5 may have a container or container (31). 3 and 5, the container / container (31) is provided with a panel (32) mounted rotatably. The panel (32) may be attached to the container / container (31) using a spring hinge (33). The container / container (31) has a front part (34) which comprises a layer (35) (eg PVC, plastic), a blister foil layer (36) and a hard plastic grid. A layer (37) may be included. The cavity (38) is provided between the hard plastic lattice layer (37) and the rear panel (42) of the container / container (31). The pill receiving trough (40) is provided as part of the container / container (31) and substantially faces the spring hinge (33) as shown.

  A release lock (39) or other closure is provided as part of the rotatably mounted panel (32) to close the panel (32) to the container / container (31). The release lock (39) may be a push-type or pull-type release lock, and the user releases the panel (32) from the connection with the container / container (31) by pressing the release lock (39). Make it possible. When the release lock (39) is pushed (or pulled), the panel (32) moves in the direction of the arrow (44) to make an acute, right or obtuse angle with the rear panel (42) of the container / container. Move to the desired position. The patient is reminded to perform an eye self-test each time the pill or other medication (24) is removed from the container / container (31).

  To remove the pill or other medication (24) from the container / container (31), the patient pushes the release lock (39), and the panel (32) is moved by the spring hinge (33) to move the arrow (44). Rotate away from the container / container (31) in the direction of. The patient then pushes the pill (24). The pill (24) ruptures the blister foil (36) and enters the cavity (38) behind the hard plastic grid (37). The hard plastic lattice (37) is provided with an opening (58) behind each pill (24), and the opening (58) is covered with a blister foil (36). When the patient pushes the pill (24) toward the rear panel (42), this force is used to immediately rupture the foil (36) behind the pill (24). The pill (24) enters the cavity (38) and falls to the pill receiving trough (40) as shown by the arrow (53). The pill receiving trough (40) may be formed by a protrusion (41), and the protrusion (41) may be shaped in a generally triangular shape as shown in cross section in FIGS. When the user retrieves the pill (24), the user then closes the panel (32) against the spring hinge (33) until the release lock (39) is secured to the tab (56).

  The panel (32) has a grid-like eye self-test chart (43) that allows the patient to diagnose macular degeneration and / or macular degeneration or age-related macular degeneration (AMD). It is possible to conduct an eye self-test on the progression of By placing an eye self-test chart (43) in front of a freely mounted panel (32), the patient performs a self-test each time the pill (24) is removed from the container / container (31). I remember that.

  The chart (43) may be a paper chart that the patient marks by hand. The chart (43) may be a touch screen that is touched by the patient to test its visual acuity. The chart (43) may be a computer monitor or computer screen instead of a touch screen and may optionally have voice activated / speech recognition (e.g. wireless microphone, Bluetooth enabled and voice recognition technology available). Etc.) Such voice activation / recognition can identify the user's response to the letters and / or symbols shown on the screen, and measure and / or monitor the patient's visual acuity under various lighting and visual conditions Can do.

  FIG. 6 shows another embodiment of the device of the present invention, generally designated by reference numeral (45). The drug take-out device (45) has a container / container (46) having an internal or hollow space (47). The blister card removal wheel (48) is housed inside the container / container (46) (47). A front panel / actuator push button (49) is provided as part of the container / container (46). When the front panel / actuator push button (49) is pressed, it takes out one pill (29). The front panel / actuator push button (49) has a grid-like eye self-test chart (50) that allows patients to develop macular degeneration and / or macular degeneration or age-related macular degeneration. It is possible to perform an eye self-test to diagnose the progression of (AMD).

  The container / container (31) has an opening (51), and when the front panel / actuator push button (49) is pressed, the pill (24) passes through the opening (51). The arrow (54) schematically shows the path of the pill (24), and when the front panel / actuator push button (49) is pressed, the pill (24) passes through the opening (51) and the blister card It is taken out from the take-out wheel (48). The pill (24) falls into the collection tray (52).

  7, 9 and 10 schematically show a pattern in which containers / containers (11), (31) and (46) are attached to an electric device (55) such as a refrigerator. Magnetic strips (27) or adhesive strips (28) may be used to secure containers / containers (11), (31), (46) to electrical equipment (55).

  The ocular kinetic offset acuity test is an interactive eye test and is incorporated herein by reference. This test may be utilized by a person with access to a computer having a mouse tracking device. In a preferred embodiment, the test is also incorporated into a touch screen with a pointer so that the patient can make a selection on the screen. In a further preferred embodiment, the test is incorporated into a pill removal device and used for disease management.

  In addition, the device can record the results of each of the patient's tests, thereby monitoring the improvement or worsening of the patient's macular disease.

  Numerous examples of eye tests are disclosed in the literature. The Eg Okay test has been conceived by Dr. William Sponsor, and MD and peripheral vision testing are built into the flash focus computer game available on the Nintendo DS. In addition, a device dedicated to monitoring patient progress is also available as a machine known as Foresee PHP (Foresee PHP) sold by NotalVision Inc. Some embodiments of the present invention allow patients and physicians to perform visual field tests or visual acuity tests using mechanisms that do not require a touch screen or dedicated device to perform the tests. Overcoming the limitations of the prior art. The game does not require speech recognition capability, as many computers do not have a microphone.

  Visual eye tests also do not require a significant amount of training and supervision by a technician who monitors the patient and becomes proficient with the test.

  Another embodiment of the present invention is a combination of a pill dispenser and a personal digital assistant (Pill-PDA), shown in FIGS.

  FIG. 11 shows a screen image (70) of the game before the start. A cursor (71) is shown in the center of the screen (70), and there are a plurality of blocks or boxes around the edge of the screen (70).

  FIG. 12 illustrates a randomly generated arrow (73) that points to one of the empty boxes (72) that surround the perimeter of the region. An arrow (73) may appear on the screen (70) within the edge of the lined box (72). The arrow (73) blinks and appears temporarily (eg, for 1 second or less). Arrow (73) may be adjusted for arrowhead size, length, width, straight, curved, black, white on black, flashing, fading in, grayscale There may also be a box-like object, similar to the box around the edge of the game as illustrated in FIGS.

  FIG. 13 shows the game after the arrow (73) disappears from the screen (73).

  FIG. 14 illustrates the direction of the mouse cursor (71) that changes according to the drag-to direction of the user. Since the direction of the mouse cursor (71) changes with the direction of the mouse rotation, the response of the target patient to visual stimulation can be measured almost immediately, and the intended movement and the actual movement of the eyes and hands are coordinated. To separate the response time and direction between the two and facilitate the use.

  FIG. 15 illustrates the movement of the mouse cursor (71) in the direction of the box (72) selected by the user, where the selected box (72) is an arrow that is flashed temporarily by the user. It is a box that I believe is suitable for.

  FIG. 16 shows positive feedback (75) to the user, helping compliance through the point system so that the user gets the highest score, thereby inciting the user's interest and improving patient compliance, Challenge the user to get a higher score. The scoring system has a small negative value due to mistakes, but if you score the user, select the correct box that gives a high score, and recognize and identify the more difficult and challenging arrow placement, It is intended to reward the user. Sounds may be played when good to encourage the patient, an avatar may guide and guide the patient on how to use the device, and may include right and left eyes. The running score from the start of the game is counted and displayed to the user on the display of the user's score (74). When used in an eye care professional's office, the test provides information that may be useful to the professional regarding changes in the patient's macula and vision. It helps reduce the burden on eye care professionals by having computer-generated conversational avatars guide them through the process. The expert can return after the patient completes the test and evaluate the results graphically as described below.

  FIG. 17 shows the cursor (71) automatically returning to the center of the field (70) so that the user's gaze is in the middle of the test before each test instance.

  FIG. 18 shows a different scenario than FIG. 16, where the user has not selected the correct box, resulting in a small subtraction from the patient score (74). The patient's score (74) will never be less than zero at any time. Depending on the characteristics and extent of the patient's illness, scoring may be adjusted to give higher points, for example, to accommodate patients with various retinal abnormalities. Known or observed retinal abnormalities may be more rigorously tested rather than random locations by selected and executed programs.

  FIG. 19 shows the user's final score (74), based on the average percentage of right and wrong choices, the area, likelihood, and type of macular abnormalities in the user are shown as circles (78) ( 79) (80) and is shown in the field grid (77).

  Figure 20 shows the ability to test over a period of time and save the results of each test over a period of time to animate anomalies in the patient's vision and facilitate future progression and improvement of the patient's disease It also shows that it will be explained with an example. FIG. 20 shows circles (81) (82) (83).

  As in FIG. 21, a stylus (90) or finger (not shown) may be used instead of mouse input. In addition to these inputs, speech recognition software such as Joystick, Thumbpad, Mouse Click, Keyboard, and Dragon Naturally Speaking integration is used, for example, for character objects, tumbling E objects, By identifying the child's target, all the requirements needed for eye-hand coordination are eliminated. In the case described later, it is not necessary to use a touch screen.

  FIG. 22 shows a photorecovery time measurement (91) where the dark screen area (92) is displayed for a time sufficient for the patient's iris to adapt to the dark illumination.

  FIG. 23 shows a bright white screen displayed to measure photo recovery time following the dark screen (92) of FIG. The box (72) may be placed elsewhere (as in the other drawings) and gradually disappears as the contrast increases (as in the arrows in the other figures) and the device Measure the time it takes to correctly see and identify this box (in other drawings, the device requires the patient to correctly look at the arrow (73) and identify the box (72) indicated by the arrow. Measure time).

  FIG. 24 shows the correct selection using the stylus (90) or mouse described in FIG.

  FIG. 25 shows a contrast sensitivity fide test with a shadow (93) in the box (72).

  FIG. 26 shows correct selection and measurement (84) of contrast sensitivity.

  In FIG. 27, a corrected Ishihara test for color vision is performed using a green arrow (94) against a red background (95), and an arrow (94) pointing to a box (72) is generated. A similar test can be done by changing the RGB color of a collection of objects and several objects (or simply showing a series of randomly collected objects in the region and the level at which the patient can identify colored objects and (Or by measuring time).

  FIG. 28 shows a pattern in which contrast sensitivity is measured everywhere in the field of view, not just at the edges, and further information about retinal abnormalities can be obtained. Field contrast sensitivity (96) may be displayed.

  FIG. 29 shows a pattern in which the photorecovery time is measured everywhere in the field of view, not just the edges, and further information about retinal abnormalities can be obtained. Field contrast sensitivity (97) may be displayed.

 The present invention is also preferably embodied as a pill dispenser having a computer including a display screen that interfaces with a user, such as a personal digital assistant or PDA.

  FIG. 30 shows one form of the pill PDA (100) (with the double-sided tape attached to the panel (32) (see FIG. 3)), the PDA (60) is the pill take-out device (11). Is attached. The screen (70) described in connection with FIGS. 11 to 29 is shown in front of the PDA (60). In this case, the PDA (60) may replace the grid (43) on the panel (32) or be mounted on the grid (43). The PDA 60 may be mounted in other containers including an extrusion type blister card. This container has, for example, a hole corresponding to a pillar portion (not shown) in the PDA (60), and the PDA (60) is attached to the container. The pill PDA may also take out bulk pills, pill magazines and can take various forms. Pill PDAs provide great convenience and compliance, especially for older people. In addition, pill PDAs are useful for monitoring both patient disease progression and pill compliance. The pill PDA may record the date and time of the last removal and remind the patient visually, wirelessly, by e-mail, text message, by phone, or by voice signal if not taken. Pill PDAs can be networked with each other, to home computers, to patient doctors, upload important data to the doctor's office, and immediately monitor patient information electronically and automatically from anywhere. It may be possible. The pill PDA may include, for example, multiple blister cards and disposable removal cartridges to integrate the entire patient's daily dosing schedule.

  FIG. 30 shows a touch screen device. However, instead of a touch screen, the screen may be a computer monitor or computer screen with optional voice activation / speech recognition (eg, wireless microphone, Bluetooth capable, including m voice recognition technology). Voice activated / recognition allows the user's response to the letters and / or symbols shown on the screen to be identified, measuring and / or monitoring the patient's vision at various lighting and visual conditions be able to.

  Combining eye self-tests with PDAs records patient compliance, progress and monitoring, and broadens accurate medical measurements. Recorded results are obtained periodically during diagnosis, and these results are reviewed by the patient's doctor or eye specialist to ensure that the expert is aware of the appearance of wet macular degeneration events and drusen. ) To help detect any increase or decrease. In the preferred embodiment, a home version is provided to the patient and the pill removal device is coupled as described above. In another embodiment, the eye test may also include a photo recovery time function, where the dark screen area is displayed for a time sufficient for the patient's iris to adapt to the dark illumination. The white screen is then displayed and gradually disappears, the contrast of the arrow pointing to the box increases, and the patient sees this arrow correctly and the time to identify the box it points to is measured. In a further embodiment, the above-described arrows are adjusted to various degrees of contrast with the background to measure changes in patient contrast sensitivity. As Sponsor explains in the patent application describing the Okay test, a game or eye test can be a useful tool for measuring a patient's visual acuity at a fixed distance from the screen. As Sponsor explained, the simultaneous measurement of visual acuity can be used to screen patients with potential macular disease, including three major eye retinal diseases: macular degeneration, glaucoma and retinopathy. Useful.

  The tests described herein may also be used to monitor medication compliance, especially for older patients, as well as memory and cognitive power (as in games like Nintendo Brain Age), and The motor nerves of movement disorders such as Parkinson may be evaluated and recorded. The devices described herein may also be programmed to automatically remind the patient and / or remove the pill and monitor compliance. This advantage can be seen, for example, in clinical trials of disease-modifying therapies specifically aimed at lowering or adjusting patient free and bound copper levels, free and bound iron levels, and free and bound zinc levels. And very useful for monitoring improvement. Such a test and retrieval device may record each activated or touched time and is used for clinical trials using a web to wirelessly collect patient data at home and monitor clinical trials. Good. This further collection of data points statistically evaluates clinical trials for disease-modifying therapies such as anti-copper therapy, providing the clinical benefit of a smaller patient population and shorter clinical trials. New hypotheses about the causal relationship between diseases, such as prospectively defined observational studies and database search studies (such as the Rush University study conducted by Martha Morris on copper and Alzheimer's disease). Can be collected and tested. Such additional clinical data points and collections therefore greatly facilitate clinical research and enable more rapid introduction of disease modifying therapies, visual function, memory and cognitive decline, dementia, Reduce health care costs related to cardiovascular diseases related to aging, and greatly improve human health and longevity.

  The pill accommodating insertion part (20) may have, for example, holes (not shown) at each corner, and a pillar part (not shown) in the container (11) is coupled to the hole, and the insertion part (20 ), When placed in the container (11), is appropriately combined with the container (11).

  The measurements disclosed herein are at standard sea surface temperature and standard pressure unless otherwise noted. All materials used or intended for human use are biocompatible unless otherwise noted. The embodiments described above are shown by way of illustration only and the scope of the present invention is limited only to the appended claims.

A list of parts and materials suitable for use in the present invention is given below.
(10) Drug take-out device
(11) Container / container
(12) Side panel
(13) Side panel
(14) Rear panel
(15) Rear panel
(16) Bottom panel
(17) Upper panel
(18) Closure flap
(19) Eye self-test chart
(20) Pill housing insert
(21) Foil layer
(22) Layer (eg PVC, plastic)
(23) Window / Opening
(24) Pill / medicine
(25) Hollow space
(26) Transparent layer
(27) Magnetic strip
(28) Adhesive strip
(29) Tab
(30) Drug removal device
(31) Container / container
(32) Panel mounted rotatably
(33) Spring hinge
(34) Front part
(35) Layer (eg PVC, plastic)
(36) Blister foil layer
(37) Hard plastic lattice layer
(38) Cavity
(39) Release lock / stopper
(40) Pill receiving trough
(41) Projection
(42) Rear panel
(43) Eye self-test chart
(44) Arrow
(45) Drug removal device
(46) Container / container
(47) Internal / hollow space
(48) Blister card removal wheel
(49) Front panel / actuator push button
(50) Eye self-test chart
(51) Opening
(52) Collection tray
(53) Arrow
(54) Arrow
(55) Electrical equipment
(56) Tab
(57) Panel / Surface
(58) Opening
(60) PDA
(70) Screen
(71) Cursor
(72) Box
(73) Arrow
(74) Score
(75) Feedback
(76) Subtraction
(77) Field grid
(78) Yen
(79) Yen
(80) Yen
(81) Yen
(82) Yen
(83) Yen
(84) Contrast sensitivity measurement
(90) Stylus
(91) Photo recovery time measurement
(92) Dark screen area
(93) Shadow
(94) Arrow
(95) Background
(96) Field contrast sensitivity
(97) Field contrast sensitivity
(100) Pill PDA

Claims (42)

a) a container having an interior for holding a medicament to be removed, an exterior, and one or more panels;
b) a diagnostic chart attached to the container;
With
The diagnostic chart is a pill removal device that allows a patient to perform macular degeneration, or an eye self-test that helps diagnose macular degeneration progression.   The apparatus of claim 1, wherein the container comprises a blister container.   The apparatus of claim 1 or 2, wherein the eye self test substantially comprises a grid. A device for containing and taking out medicines for patients diagnosed with a type of macular degeneration,
a) configured to include at least one panel and multiple doses of medication administered to said patient to prevent macular degeneration, slow progression of macular degeneration, or ameliorate macular degeneration A container having an interior;
b) a diagnostic chart on the panel that enables the patient to perform an eye self-test;
With
The eye self-test is associated with a diagnosis of macular degeneration and / or progression of macular degeneration.   The apparatus of claim 4, wherein the container has one or more exterior panels and the diagnostic chart is on one of the exterior panels.   The apparatus of claim 4, wherein the interior includes a blister pack.   The apparatus of claim 4, wherein the interior includes a blister card ejection wheel.   The apparatus of claim 4, further comprising a collection tray for receiving a single dose of medication to be administered to the patient.   The apparatus of claim 4, further comprising a hanger supporting the container on a substantially vertically disposed surface.   The apparatus of claim 9, wherein the hanger includes a magnet.   A device further comprising an adhesive container containing an eye self test.   The apparatus of claim 4, wherein the panel is movably attached to the container.   The apparatus of claim 4, wherein the panel is movably attached to the container using a hinge.   14. A device according to claim 12 or 13, wherein the movably mounted panel is movable to expose the medicament to be removed.   15. The device of claim 14, wherein the medication is contained in multiple sections of a blister pack.   The apparatus of claim 4, wherein the diagnostic chart is a grid.   The apparatus of claim 16, wherein the grid is an Amsler grid.   The apparatus of claim 4, wherein the diagnostic chart is a peripheral supervision self-test chart. In a medicine takeout container provided with a container having an interior and an exterior part,
a) the interior is subdivided into a plurality of pill holding spaces, each space being configured to contain an individual dose of medicament;
b) the container has a panel with a diagnostic eye test chart that allows the user to perform an eye self test for macular degeneration;
c) the container contains instructions that instruct the user to perform an eye self-test when the user removes one or more doses of medication;
Drug take-out container.   The medicine take-out container according to claim 19, wherein the plurality of pill holding spaces are blister container spaces.   20. The drug retrieval container of claim 19, further comprising a tray for receiving the removed pill.   20. The medicine retrieval container according to claim 19, wherein the container has a plurality of exterior panels, and the vision test chart is attached to one of the plurality of exterior panels.   20. The medicine retrieval container according to claim 19, wherein the exterior panel is connected to the container by a hinge.   The medicine take-out container according to claim 19, wherein the exterior panel is hingedly connected to the container together with the vision test chart.   20. The drug retrieval container of claim 19, wherein the container includes a rotating wheel that carries multiple doses of drug.   20. The medicine retrieval container according to claim 19, wherein the instruction instructs the user to perform an eye self-test by marking the eye test chart according to the written instruction. In a medicine take-out container comprising a container having an interior and an exterior part,
a) the interior is subdivided into a plurality of pill holding spaces, each space being configured to contain an individual dose of medicament;
b) the container has a panel with a diagnostic eye test chart that allows the user to perform an eye self test for macular degeneration;
c) the container is mounted on a substantially vertically oriented surface so that the vision test chart is displayed when the container is mounted on the surface;
Drug take-out container. a) a container having an interior for holding a medicament to be removed;
b) a display screen mounted on the container;
With
A pill removal device, wherein the display screen assists the patient in performing a macular degeneration, or an eye self-test that helps diagnose the progression of macular degeneration.   30. The apparatus of claim 28, wherein the display screen is a touch screen.   30. The apparatus of claim 28, further comprising an input device connected to the display screen and enabling a patient to respond to visual stimuli on the display screen.   32. The apparatus of claim 30, wherein the input device is a mouse.   32. The apparatus of claim 30, wherein the input device is a microphone.   30. The apparatus of claim 28, wherein the container comprises a blister container.   30. The apparatus of claim 28, wherein the interior comprises a blister pack.   30. The apparatus of claim 28, wherein the interior includes a blister card ejection wheel.   30. The apparatus of claim 28, further comprising a collection tray for receiving a dose of medication to be administered to the patient.   30. The apparatus of claim 28, further comprising a hanger that supports the container on a substantially vertically disposed surface. a) a container having an interior for holding a medicament to be removed;
b) a PDA attached to the container;
With
The PDA includes a display screen that allows a patient to perform macular degeneration, or a self-test of the eye that helps diagnose the progression of macular degeneration.   39. The apparatus of claim 38, wherein the PDA includes software that generates an eye self test performed by the patient.   40. The apparatus of claim 39, wherein the PDA includes software that records the results of the eye self test. A blister pack that holds a medicament to be removed and is used by a patient to prevent macular degeneration, slow the progression of macular degeneration, or ameliorate macular degeneration, and the blister combined with a column of a container A pill receiving insert with a hole in the pack,
a) a diagnostic chart attached to the container to help the patient perform macular degeneration, or a self-test of the eye that helps to diagnose the progression of macular degeneration, or
b) a display screen attached to the container that helps the patient to perform a self-test of the eye that helps diagnose macular degeneration, or progression of macular degeneration,
Any one of the above is on the container or attached to the container.   Invention substantially as shown and described in the specification.

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